Human Vaccines & Immunotherapeutics – July 2014 Volume 10, Issue 7

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
July 2014 Volume 10, Issue 7
http://www.landesbioscience.com/journals/vaccines/toc/volume/10/issue/7/

Effect of the decision-making process in the family on HPV vaccination rates among adolescents 9–17 years of age
Abbey B Berenson*, Tabassum H Laz, Jacqueline M Hirth, Christine J McGrath, Mahbubur Rahman
Abstract
The purpose of this study was to examine the relationship between human papillomavirus (HPV) vaccine uptake among adolescents aged 9–17 years and the decision-making process used by families in determining whether to vaccinate their children against HPV. A cross-sectional sample of women with at least one child aged 9–17 years (n = 1256) was recruited from 3 reproductive health clinics in Southeast Texas during 2011–2013. Self-administered survey included questions about the HPV vaccination decision-making process, HPV vaccine uptake (initiation and 3-dose series completion), and demographics. Among mothers with at least one 9 to 17-year-old daughter (n = 783), 40% independently decided whether or not to vaccinate their daughter against HPV, 22% involved their husbands/partners, and 31% their daughters. Only 7% of respondents reported other formats in the decision-making (husband/partner alone or daughter alone). Similarly, for women with at least one eligible son (n = 759), 39% decided alone, 30% with their husbands/partners, 24% with their sons, and 7% reported other formats. Among mothers with a daughter, those who made the decision independently were more likely to report that their daughters had initiated the HPV vaccine series (30%) compared with women who included their husbands/partners (10%) or daughters (20%) in the decision process or stated other types (18%) of decision making (P < 0.001). The respective figures for the completion of the entire series among daughters were 16%, 6%, 11%, and 11% (P = 0.012). Among mothers with a son, a similar scenario was observed for vaccine initiation (17%, 4%, 10%, and 0%, respectively) (P < 0.001) and completion (7%, 1%, 4%, and 0%, respectively) (P = 0.003). These associations remained significant after adjusting for confounder variables. Awareness programs to increase HPV vaccine uptake should include both parents and children, as all have an important role in deciding whether or not children will be vaccinated.

Human papillomaviruses-related cancers: Presence and prevention strategies in the Middle East and North African Regions
Ala-Eddin Al Moustafa*, Rana Al-Awadhi, Nabiha Missaoui, Ishag Adam, Raika Durusoy, Lina Ghabreau, Nizar Akil, Hussain Gadelkarim Ahmed, Amber Yasmeen, Ghazi Alsbeih
Abstract
Human papillomavirus (HPV) infections are estimated to be the most common sexually transmitted infections worldwide. Meanwhile, it is well established that infection by high-risk HPVs is considered the major cause of cervical cancer since more than 96% of these cancers are positive for high-risk HPVs, especially types 16 and 18. Moreover, during the last 2 decades, numerous studies pointed-out the possible involvement of high-risk HPV in several human carcinomas including head and neck, colorectal and breast cancers. The association between high-risk HPVs and cervical cancer and potentially other human malignancies would necessitate the introduction of vaccines which were generated against the 2 most frequent high-risk HPVs (HPV types 16 and 18) worldwide, including the Middle East (ME) as well as North African countries. The presence of high-risk HPVs in the pathogenesis of human cancers in the ME, which is essential in order to evaluate the importance of vaccination against HPVs, has not been fully investigated yet. In this review, we present an overview of the existing epidemiological evidence regarding the presence of HPV in human cancers in the ME and the potential impact of vaccination against HPV infections and its outcome on human health in this region.

A few years later: Update of the cost-effectiveness of infant pneumococcal vaccination in Dutch children
Pepijn Vemer*, Maarten J Postma
Abstract
This study aimed to calculate the cost-effectiveness of infant pneumococcal vaccination in the Netherlands, using the 13-valent PCV13 vs. the currently used 10-valent PCV10. We adapted a previously published model, using recent estimates of epidemiological and efficacy data. In 12 scenarios, we explored the impact of different assumptions on the incremental cost-effectiveness ration (ICER) of PCV13 over PCV10.Taking only direct effects on invasive pneumococcal disease into account, PCV13 was not found to be cost-effective, at a price difference of €11 per dose. If herd protection, replacement and non-invasive disease were also taken into account, the ICER of PCV13 compared with PCV10 was below €30 000/QALY gained in 11 of 12 scenarios. PCV13 was considered dominant in the primary scenario with a price difference below €2.63 per dose.

Annual influenza vaccination: Uptake, barriers, and enablers among student health care providers at the University of Notre Dame Australia, Fremantle
David A Kelly*, David J Macey, Donna B Mak
Abstract
Despite national and international recommendations, annual influenza vaccination uptake among health care providers (HCPs) remains sub-optimal. This study investigated the uptake, enablers, and barriers to annual influenza vaccination in medicine, nursing, and physiotherapy students at the University of Notre Dame Australia, Fremantle, using an online survey and semi-structured interviews. In 2013, uptake rate of influenza vaccination was 36.3% (95% CI = 31.8–40.8%). Employment as a HCP (OR 1.6, 95% CI 1.1–2.5), being a medical student (OR 2.5, 95% CI 1.2–5.1) and eligibility for government-funded vaccine (OR 7.1, 95% CI 2.7–18.6) were independently associated with increased uptake. Awareness, cost, and convenience were identified as key barriers to vaccination with interview data suggesting that raising awareness of the benefits of influenza vaccination, along with improving student HCPs’ access to affordable, convenient vaccination are likely to improve uptake. Responsibility to increase uptake should be shared between universities and student HCPs.

Cost-effectiveness of vaccination against herpes zoster
Pieter T de Boer*, Jan C Wilschut, Maarten J Postma
Abstract
Herpes zoster (HZ) is a common disease among elderly, which may develop into a severe pain syndrome labeled postherpetic neuralgia (PHN). A live-attenuated varicella zoster virus vaccine has been shown to be effective in reducing the incidence and burden of illness of HZ and PHN, providing the opportunity to prevent significant health-related and financial consequences of HZ. In this review, we summarize the available literature on cost-effectiveness of HZ vaccination and discuss critical parameters for cost-effectiveness results. A search in PubMed and EMBASE was performed to identify full cost-effectiveness studies published before April 2013. Fourteen cost-effectiveness studies were included, all performed in western countries. All studies evaluated cost-effectiveness among elderly above 50 years and used costs per quality-adjusted life year (QALY) gained as primary outcome. The vast majority of studies showed vaccination of 60- to 75-year- old individuals to be cost-effective, when duration of vaccine efficacy was longer than 10 years. Duration of vaccine efficacy, vaccine price, HZ incidence, HZ incidence and discount rates were influential to the incremental cost-effectiveness ratio (ICER). HZ vaccination may be a worthwhile intervention from a cost-effectiveness point of view. More extensive reporting on methodology and more detailed results of sensitivity analyses would be desirable to address uncertainty and to guarantee optimal comparability between studies, for example regarding model structure, discounting, vaccine characteristics and loss of quality of life due to HZ and PHN.

Influenza vaccine hesitancy in a low-income community in central New York State
Manika Suryadevara*, Cynthia A Bonville, Paula F Rosenbaum, Joseph B Domachowske
Abstract
Objective: Influenza vaccine (IV) coverage rates remain suboptimal among US adults. Socioeconomic disparities exist in IV coverage. We describe influenza vaccine attitudes among a low-income community in central New York.
Methods: Adults attending a Salvation Army function during December 2012 were surveyed regarding IV including their intention to be immunized. On-site IV was offered to eligible participants.
Results: The 1041 participants included Whites (non-Hispanics), African Americans, Hispanics, Native Americans, and multi-racial ethnicities. At time of enrollment, 386 (37%) participants had already received 2012–13 IV. Of the 655 unimmunized participants, 299 (46%) stated intent to receive IV, evenly distributed by age, gender, and ethnicity. Of the 312 participants who declined IV, 46% did so because of IV misperceptions. Of the 299 participants who intended to receive vaccine but had not yet done so, 284 (95%) stated the reason for delay was difficult access to vaccine. Intent to receive vaccine was strongly associated with the belief that IV is safe and/or effective (P < 0.05).
Conclusion: IV misperceptions regarding IV efficacy and safety result in suboptimal vaccine uptake in this low-income community, regardless of age, gender, or ethnicity.

Infectious Diseases of Poverty [Accessed 2 August 2014]

Infectious Diseases of Poverty
[Accessed 2 August 2014]
http://www.idpjournal.com/content

Scoping Review
Tackling the existing burden of infectious diseases in the developing world: existing gaps and way forward
Zulfiqar A Bhutta, Rehana A Salam, Jai K Das and Zohra S Lassi
Author Affiliations
Infectious Diseases of Poverty 2014, 3:28 doi:10.1186/2049-9957-3-28
Published: 1 August 2014
Abstract (provisional)
This series evaluates the effectiveness of community-based interventions (CBIs) to prevent and control infectious diseases of poverty (IDoP). Evidence from our reviews suggests that CBIs and school-based delivery platforms are effective in averting risk behaviors and reducing the disease burden. Co-implementation of interventions through existing community-based programs including immunization campaigns, antenatal care (ANT), and maternal and child health programs have the potential to scale-up interventions for IDoP. Future research should focus on the process of developing and implementing efficient community-based programs through a comprehensive approach, and to gauge the effectiveness of various existing delivery models in order to improve morbidity and mortality outcomes.

Scoping Review
The conceptual framework and assessment methodology for the systematic reviews of community-based interventions for the prevention and control of infectious diseases of poverty
Zohra S Lassi, Rehana A Salam, Jai K Das and Zulfiqar A Bhutta
Author Affiliations
Infectious Diseases of Poverty 2014, 3:22 doi:10.1186/2049-9957-3-22
Published: 31 July 2014
Abstract (provisional)
This paper describes the conceptual framework and the methodology used to guide the systematic reviews of community-based interventions (CBIs) for the prevention and control of infectious diseases of poverty (IDoPs). We adapted the conceptual framework from the 3ie work on the ‘Community-Based Intervention Packages for Preventing Maternal Morbidity and Mortality and Improving Neonatal Outcomes’ to aid in the analyzing of the existing CBIs for IDoPs. The conceptual framework revolves around objectives, inputs, processes, outputs, outcomes, and impacts showing the theoretical linkages between the delivery of the interventions targeting these diseases through various community delivery platforms and the consequent health impacts. We also describe the methodology undertaken to conduct the systematic reviews and the meta-analyses.

Scoping Review
Global burden, distribution, and interventions for infectious diseases of poverty
Zulfiqar A Bhutta, Johannes Sommerfeld, Zohra S Lassi, Rehana A Salam and Jai K Das
Author Affiliations
Infectious Diseases of Poverty 2014, 3:21 doi:10.1186/2049-9957-3-21
Published: 31 July 2014
Abstract (provisional)
Infectious diseases of poverty (IDoPs) disproportionately affect the poorest populations in the world and contribute to a cycle of poverty as a result of decreased productivity ensuing from long-term illness, disability, and social stigma. In 2010, the global deaths from the human immunodeficiency virus (HIV)/ acquired immunodeficiency syndrome (AIDS) have increased to 1.5 million, and malaria mortality rose to 1.17 million. Mortality from neglected tropical diseases (NTDs) rose to 152,000, while tuberculosis (TB) killed 1.2 million people that same year. Substantial regional variations exist in the distribution of these diseases as they are primarily concentrated in rural areas of Sub-Saharan Africa, Asia, and Latin America, with geographic overlap and high levels of co-infection. Evidence-based interventions exist to prevent and control these diseases, however, the coverage still remains low with an emerging challenge of antimicrobial resistance. Therefore, community-based delivery platforms are increasingly being advocated to ensure sustainability and combat co-infections.Because of the high morbidity and mortality burden of these diseases, especially in resource-poor settings, it is imperative to conduct a systematic review to identify strategies to prevent and control these diseases. Therefore, we have attempted to evaluate the effectiveness of one of these strategies, that is community-based delivery for the prevention and treatment of IDoPs. In this paper, we describe the burden, epidemiology, and potential interventions for IDoPs. In subsequent papers of this series, we describe the analytical framework and the methodology used to guide the systematic reviews, and report the findings and interpretations of our analyses of the impact of community-based strategies on individual IDoPs.

Lancet Editorial: Polio eradication – placing health before conflict

The Lancet
Aug 02, 2014 Volume 384 Number 9941 p377 – 468 e30 – 31
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Polio eradication: placing health before conflict
The Lancet
In a recent interview with Reuters, Bill Gates was optimistic that efforts to eradicate polio in Nigeria could result in the country being declared free of the disease by 2018. Although a commendable goal, ongoing violence in Nigeria makes this timescale unrealistic. National polio eradication efforts have already been hindered by local insurgency groups, and, until health is prioritised over conflict, polio will continue to spread between those who are vulnerable.
Aside from Nigeria, polio is also endemic in other conflict-ridden countries, namely Afghanistan and Pakistan, and 38 cases have emerged in Syria and Iraq. Access to vaccines in some countries is made almost impossible by ongoing conflict. Indeed, a July report by UNICEF on polio in the Middle East outlines the many challenges faced by people working in Syria to eliminate polio. Health workers have difficulty vaccinating the 765 500 children who live in areas under siege or inaccessible because of fighting. Vaccinators are trying desperately to reach every child, frequently being held at gunpoint or having their medical equipment targeted, and often risking their lives to travel into dangerous areas. To prevent polio transmission, the report recommends that health workers must be granted unrestricted access across the country, and health centres and equipment, which are already in short supply, should never be targeted.
On May 5, the WHO Director-General Margaret Chan announced that the spread of polio was a public health emergency of international concern. And earlier this year, WHO placed travel restrictions on Cameroon, Pakistan, and Syria to prevent the international spread of polio, meaning that people from these countries are required to receive a dose of polio vaccine before they travel. Although a step in the right direction, polio spread needs to be curbed within countries themselves. In countries of conflict, it is essential for the neutrality of health care to be respected and that a long enough ceasefire is maintained to allow all children access not only to polio vaccines but also to all basic health care that is currently denied.

Contribution of six risk factors to achieving the 25×25 non-communicable disease mortality reduction target: a modelling study

The Lancet
Aug 02, 2014 Volume 384 Number 9941 p377 – 468 e30 – 31
http://www.thelancet.com/journals/lancet/issue/current

Contribution of six risk factors to achieving the 25×25 non-communicable disease mortality reduction target: a modelling study
Vasilis Kontis PhD a, Colin D Mathers PhD b, Prof Jürgen Rehm PhD e f g, Gretchen A Stevens DSc b, Kevin D Shield MHSc e, Prof Ruth Bonita PhD h, Leanne M Riley MSc c, Vladimir Poznyak PhD d, Prof Robert Beaglehole DSc h, Prof Majid Ezzati PhD a
Summary
Background
Countries have agreed to reduce premature mortality (defined as the probability of dying between the ages of 30 years and 70 years) from four main non-communicable diseases (NCDs)—cardiovascular diseases, chronic respiratory diseases, cancers, and diabetes—by 25% from 2010 levels by 2025 (referred to as 25×25 target). Targets for selected NCD risk factors have also been agreed on. We estimated the contribution of achieving six risk factor targets towards meeting the 25×25 mortality target.
Methods
We estimated the impact of achieving the targets for six risk factors (tobacco and alcohol use, salt intake, obesity, and raised blood pressure and glucose) on NCD mortality between 2010 and 2025. Our methods accounted for multi-causality of NCDs and for the fact that when risk factor exposure increases or decreases, the harmful or beneficial effects on NCDs accumulate gradually. We used data for risk factor and mortality trends from systematic analyses of available country data. Relative risks for the effects of individual and multiple risks, and for change in risk after decreases or increases in exposure, were from re-analyses and meta-analyses of epidemiological studies.
Findings
If risk factor targets are achieved, the probability of dying from the four main NCDs between the ages of 30 years and 70 years will decrease by 22% in men and by 19% in women between 2010 and 2025, compared with a decrease of 11% in men and 10% in women under the so-called business-as-usual trends (ie, projections based on current trends with no additional action). Achieving the risk factor targets will delay or prevent more than 37 million deaths (16 million in people aged 30—69 years and 21 million in people aged 70 years or older) from the main NCDs over these 15 years compared with a situation of rising or stagnating risk factor trends. Most of the benefits of achieving the risk factor targets, including 31 million of the delayed or prevented deaths, will be in low-income and middle-income countries, and will help to reduce the global inequality in premature NCD mortality. A more ambitious target on tobacco use (a 50% reduction) will almost reach the target in men (>24% reduction in the probability of death), and enhance the benefits to a 20% reduction in women.
Interpretation
If the agreed risk factor targets are met, premature mortality from the four main NCDs will decrease to levels that are close to the 25×25 target, with most of these benefits seen in low-income and middle-income countries. On the basis of mortality benefits and feasibility, a more ambitious target than currently agreed should be adopted for tobacco use.
Funding
UK MRC.

Lancet Series: Every Newborn [Aug 02, 2014]

The Lancet
Aug 02, 2014 Volume 384 Number 9941 p377 – 468 e30 – 31
http://www.thelancet.com/journals/lancet/issue/current

Every Newborn: health-systems bottlenecks and strategies to accelerate scale-up in countries
Kim E Dickson, Aline Simen-Kapeu, Mary V Kinney, Luis Huicho, Linda Vesel, Eve Lackritz, Joseph de Graft Johnson, Severin von Xylander, Nuzhat Rafique, Mariame Sylla, Charles Mwansambo, Bernadette Daelmans, Joy E Lawn, for The Lancet Every Newborn Study Group
Preview
Universal coverage of essential interventions would reduce neonatal deaths by an estimated 71%, benefit women and children after the first month, and reduce stillbirths. However, the packages with the greatest effect (care around birth, care of small and ill newborn babies), have low and inequitable coverage and are the most sensitive markers of health system function. In eight of the 13 countries with the most neonatal deaths (55% worldwide), we undertook a systematic assessment of bottlenecks to essential maternal and newborn health care, involving more than 600 experts.

Every Newborn: From evidence to action to deliver a healthy start for the next generation
Elizabeth Mason, Lori McDougall, Joy E Lawn, Anuradha Gupta, Mariam Claeson, Yogan Pillay, Carole Presern, Martina Baye Lukong, Gillian Mann, Marijke Wijnroks, Kishwar Azad, Katherine Taylor, Allison Beattie, Zulfiqar A Bhutta, Mickey Chopra, for The Lancet Every Newborn Study Group , on behalf of the Every Newborn Steering Committee
Preview |
Remarkable progress has been made towards halving of maternal deaths and deaths of children aged 1–59 months, although the task is incomplete. Newborn deaths and stillbirths were largely invisible in the Millennium Development Goals, and have continued to fall between maternal and child health efforts, with much slower reduction. This Series and the Every Newborn Action Plan outline mortality goals for newborn babies (ten or fewer per 1000 livebirths) and stillbirths (ten or fewer per 1000 total births) by 2035, aligning with A Promise Renewed target for children and the vision of Every Woman Every Child.

Increasing Provision of Adolescent Vaccines in Primary Care: A Randomized Controlled Trial

Pediatrics
August 2014, VOLUME 134 / ISSUE 2
http://pediatrics.aappublications.org/current.shtml

Article
Increasing Provision of Adolescent Vaccines in Primary Care: A Randomized Controlled Trial
Melissa B. Gilkey, PhDa,b, Amanda M. Dayton, MAc, Jennifer L. Moss, MSPHb, Alicia C. Sparks, MPHb, Amy H. Grimshaw, MS, MSWc, James M. Bowling, PhDb, and Noel T. Brewer, PhDa,b
Author Affiliations
aLineberger Comprehensive Cancer Center, and
bGillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina; and
cNorth Carolina Division of Public Health, Raleigh, North Carolina
Abstract
OBJECTIVES: To assess the effectiveness of in-person and webinar-delivered AFIX (Assessment, Feedback, Incentives, and eXchange) consultations for increasing adolescent vaccine coverage.
METHODS: We randomly assigned 91 primary care clinics in North Carolina, serving 107 443 adolescents, to receive no consultation or an in-person or webinar AFIX consultation. We delivered in-person consultations in April through May 2011 and webinar consultations in May through August 2011. The state’s immunization registry provided vaccine coverage data for younger patients (ages 11–12 years) and older patients (ages 13–18 years) for 3 adolescent vaccines: tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap); meningococcal; and human papillomavirus (HPV) vaccines (≥1 dose, females only).
RESULTS: At the 5-month follow-up, AFIX consultations increased vaccine coverage among younger adolescents. Patients in the in-person arm experienced coverage changes that exceeded those in the control arm for Tdap (3.4% [95% confidence interval (CI): 2.2 to 4.6]), meningococcal (4.7% [95% CI: 2.3 to 7.2], and HPV (1.5% [95% CI: 0.3 to 2.7]) vaccines. Patients in the webinar versus control arm also experienced larger changes for these vaccines. AFIX did little to improve coverage among older adolescents. At 1 year, the 3 arms showed similar coverage changes. The effectiveness of in-person and webinar consultations was not statistically different at either time point (all, P >.05).
CONCLUSIONS: Webinar AFIX consultations were as effective as in-person consultations in achieving short-term increases in vaccine coverage for younger adolescents. AFIX consultations for adolescents need improvement to have a stronger and more durable impact, especially for HPV vaccine.

Invasive Pneumococcal Disease After Implementation of 13-Valent Conjugate Vaccine

Pediatrics
August 2014, VOLUME 134 / ISSUE 2
http://pediatrics.aappublications.org/current.shtml

Article
Invasive Pneumococcal Disease After Implementation of 13-Valent Conjugate Vaccine
Pui-Ying Iroh Tam, MDa, Lawrence C. Madoff, MDb,c, Brandon Coombes, BSd, and Stephen I. Pelton, MDe
Author Affiliations
aUniversity of Minnesota Children’s Hospital, Minneapolis, Minnesota;
bMassachusetts Department of Public Health, Boston, Massachusetts;
cUniversity of Massachusetts Medical School, Worcester, Massachusetts;
dClinical and Translational Science Institute, University of Minnesota, Minneapolis, Minnesota; and
eBoston University Medical Center, Boston, Massachusetts
Abstract
OBJECTIVE: To examine whether there is a different clinical profile and severity of invasive pneumococcal disease (IPD) in children caused by nonvaccine types in the era of 13-valent pneumococcal conjugate vaccine (PCV13).
METHODS: Observational study of childhood IPD in Massachusetts based on state public health surveillance data comparing pre-PCV13 (2007–2009) and post-PCV13 (2010–2012) eras.
RESULTS: There were 168 pre-PCV13 cases of IPD and 85 post-PCV13 cases of IPD in Massachusetts children ≤5 years of age. PCV13 serotypes declined by 18% in the first 2 years after PCV13 use (P = .011). In the post-PCV13 phase, a higher proportion of children were hospitalized (57.6% vs 50.6%), and a higher proportion of children had comorbidity (23.5% vs 19.6%). Neither difference was statistically significant, nor were comparisons of IPD caused by vaccine and nonvaccine types. Children with comorbidities had higher rates of IPD caused by a nonvaccine type (27.6% vs 17.2%; P = .085), were more likely to be hospitalized (80.4% vs 50%; P < .0001), and were more likely to have a longer hospital stay (median of 3 days vs 0.5 days; P = .0001).
CONCLUSIONS: Initial data suggest that nonvaccine serotypes are more common in children with underlying conditions, who have greater morbidity from disease. In the post-PCV13 era, a larger proportion of patients are hospitalized, but mortality rates are unchanged. Routine vaccination with PCV13 may not be enough to reduce the risk in patients with comorbidity.

Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review

Pediatrics
August 2014, VOLUME 134 / ISSUE 2
http://pediatrics.aappublications.org/current.shtml

Review Article
Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review
Margaret A. Maglione, MPPa, Lopamudra Das, MPHa, Laura Raaen, MPHa, Alexandria Smith, MPHa, Ramya Chari, PhDa, Sydne Newberry, PhDa, Roberta Shanman, MLSa, Tanja Perry, BHMa, Matthew Bidwell Goetz, MDb, and Courtney Gidengil, MD, MPHa,c
Author Affiliations
aRAND Corporation, Santa Monica, California;
bVA Greater Los Angeles Healthcare System and David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; and
cBoston Children’s Hospital, Boston, Massachusetts
Abstract
BACKGROUND: Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States.
METHODS: Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient.
RESULTS: Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported.
CONCLUSIONS: We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide.

Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine during 18 Months after Vaccination

PLoS Medicine
(Accessed 2 August 2014)
http://www.plosmedicine.org/

Research Article
Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine during 18 Months after Vaccination: A Phase 3 Randomized, Controlled Trial in Children and Young Infants at 11 African Sites
The RTS,S Clinical Trials Partnership (2014) mail
Published: July 29, 2014
DOI: 10.1371/journal.pmed.1001685
Abstract
Background
A malaria vaccine could be an important addition to current control strategies. We report the safety and vaccine efficacy (VE) of the RTS,S/AS01 vaccine during 18 mo following vaccination at 11 African sites with varying malaria transmission.
Methods and Findings
6,537 infants aged 6–12 wk and 8,923 children aged 5–17 mo were randomized to receive three doses of RTS,S/AS01 or comparator vaccine.
VE against clinical malaria in children during the 18 mo after vaccine dose 3 (per protocol) was 46% (95% CI 42% to 50%) (range 40% to 77%; VE, p VE against clinical malaria in infants was 27% (95% CI 20% to 32%, per protocol; 27% [95% CI 21% to 33%], ITT), with no significant protection against severe malaria, malaria hospitalization, or all-cause hospitalization.
Post-vaccination anti-circumsporozoite antibody geometric mean titer varied from 348 to 787 EU/ml across sites in children and from 117 to 335 EU/ml in infants (per protocol).
VE waned over time in both age categories (Schoenfeld residuals p<0.001). The number of clinical and severe malaria cases averted per 1,000 children vaccinated ranged across sites from 37 to 2,365 and from −1 to 49, respectively; corresponding ranges among infants were −10 to 1,402 and −13 to 37, respectively (ITT). Meningitis was reported as a serious adverse event in 16/5,949 and 1/2,974 children and in 9/4,358 and 3/2,179 infants in the RTS,S/AS01 and control groups, respectively.
Conclusions
RTS,S/AS01 prevented many cases of clinical and severe malaria over the 18 mo after vaccine dose 3, with the highest impact in areas with the greatest malaria incidence. VE was higher in children than in infants, but even at modest levels of VE, the number of malaria cases averted was substantial. RTS,S/AS01 could be an important addition to current malaria control in Africa.
Trial registration
http://www.ClinicalTrials.gov NCT00866619

Editors’ Summary
Background
Every year, more than 200 million cases of malaria occur worldwide, and more than 600,000 people, mainly children living in sub-Saharan Africa, die from this parasitic disease. Malaria parasites are transmitted to people through the bites of infected night-flying mosquitoes and cause fever that needs to be treated promptly with anti-malarial drugs to prevent anemia (a reduction in red blood cell numbers) and life-threatening organ damage. Malaria transmission can be prevented by using long-lasting insecticides sprayed on the indoor walls of homes to kill the mosquitoes that spread the malaria parasite or by sleeping under insecticide-treated nets to avoid mosquito bites and further reduce mosquito numbers. Widespread use of these preventative measures, together with the introduction of artemisinin combination therapy (an effective anti-malarial treatment), has reduced the global burden of malaria by 45% in all age groups, and by 51% among young children, since 2000.
Why Was This Study Done?
Unfortunately, the emergence of insecticide and drug resistance is threatening this advance in malaria control. Moreover, additional interventions—specifically, effective malaria vaccines—will be needed to eliminate malaria in the large areas of Africa where malaria transmission remains high. Currently, there is no licensed malaria vaccine, but RTS,S/AS01, the most advanced malaria vaccine candidate, is undergoing phase 3 clinical trials (the last stage of testing before licensing) in infants and children in seven African countries. The RTS,S Clinical Trials Partnership reported encouraging results on the efficacy and safety of RTS,S/AS01 during 12 months of follow-up in 2011 and 2012. Here, researchers report on the 18-month efficacy and safety of RTS,S/AS01. Vaccine efficacy (VE) is the reduction in the incidence of a disease (the number of new cases that occur in a population in a given period) among trial participants who receive the vaccine compared to the incidence among participants who do not receive the vaccine.
What Did the Researchers Do and Find?
The researchers randomly assigned 6,537 infants aged 6–12 weeks and 8,923 children aged 5–17 months to receive three doses of RTS,S/AS01 or a control vaccine. During 18 months of follow-up, there were 0.69 episodes of clinical malaria (a high temperature and parasites in the blood) per person-year among the children who received all the planned doses of RTS,S/AS01 (the “per protocol” population) and 1.17 episodes per person-year among the control children—a VE against clinical malaria in the per-protocol population of 46%. A similar VE was seen in an intention-to-treat analysis that included all the enrolled children, regardless of whether they received all of the planned vaccine doses; intention-to-treat analyses reflect the real-life situation—in which children sometimes miss vaccine doses—better than per-protocol analyses. In intention-to-treat analyses, the VE among children against severe malaria (fever, parasites in the blood, and symptoms such as anemia) and hospitalization for malaria was 34% and 41%, respectively. Among infants, the VE against clinical malaria was 27% in both per-protocol and intention-to-treat analyses; the vaccine showed no protection against severe malaria or hospitalization. In both infants and children, VE waned with time since vaccination. Across all the study sites, RTS,S/AS01 averted an average of 829 and 449 cases of clinical malaria per 1,000 children and infants vaccinated, respectively. Finally, the serious adverse event meningitis (inflammation of the tissues lining the brain and spinal cord) occurred more frequently in trial participants given RTS,S/AS01 than in those given the control vaccine, but the incidence of other serious adverse events was similar in both groups of participants.
What Do These Findings Mean?
These and other findings show that, during 18 months of follow-up, vaccination of children and young infants with RTS,S/AS01 prevented many cases of clinical and severe malaria and that the impact of vaccination was highest in regions with the highest incidence of malaria. They indicate, as in the earlier analysis, that the VE against clinical and severe malaria is higher in children than in young infants and suggest that protection wanes over time. Whether or not the vaccine played a causal role in the observed cases of meningitis cannot be determined from these results, and the occurrence of meningitis will be followed closely during the remainder of the trial. Other study limitations (for example, variations in the clinical characteristics of participants from one center to another) may also affect the accuracy of these findings and their interpretation. However, by showing that even a modest VE can avert a substantial number of malaria cases, these findings suggest that vaccination with RTS,S/AS01 could have a major public health impact in sub-Saharan Africa

Using Mobile Health (mHealth) and Geospatial Mapping Technology in a Mass Campaign for Reactive Oral Cholera Vaccination in Rural Haiti

PLoS Neglected Tropical Diseases
(Accessed 2 August 2014)
http://www.plosntds.org/

Research Article
Using Mobile Health (mHealth) and Geospatial Mapping Technology in a Mass Campaign for Reactive Oral Cholera Vaccination in Rural Haiti
Jessica E. Teng, Dana R. Thomson, Jonathan S. Lascher, Max Raymond, Louise C. Ivers
Published: July 31, 2014
DOI: 10.1371/journal.pntd.0003050
Abstract
Background
In mass vaccination campaigns, large volumes of data must be managed efficiently and accurately. In a reactive oral cholera vaccination (OCV) campaign in rural Haiti during an ongoing epidemic, we used a mobile health (mHealth) system to manage data on 50,000 participants in two isolated communities.
Methods
Data were collected using 7-inch tablets. Teams pre-registered and distributed vaccine cards with unique barcodes to vaccine-eligible residents during a census in February 2012. First stored on devices, data were uploaded nightly via Wi-fi to a web-hosted database. During the vaccination campaign between April and June 2012, residents presented their cards at vaccination posts and their barcodes were scanned. Vaccinee data from the census were pre-loaded on tablets to autopopulate the electronic form. Nightly analysis of the day’s community coverage informed the following day’s vaccination strategy. We generated case-finding reports allowing us to identify those who had not yet been vaccinated.
Results
During 40 days of vaccination, we collected approximately 1.9 million pieces of data. A total of 45,417 people received at least one OCV dose; of those, 90.8% were documented to have received 2 doses. Though mHealth required up-front financial investment and training, it reduced the need for paper registries and manual data entry, which would have been costly, time-consuming, and is known to increase error. Using Global Positioning System coordinates, we mapped vaccine posts, population size, and vaccine coverage to understand the reach of the campaign. The hardware and software were usable by high school-educated staff.
Conclusion
The use of mHealth technology in an OCV campaign in rural Haiti allowed timely creation of an electronic registry with population-level census data, and a targeted vaccination strategy in a dispersed rural population receiving a two-dose vaccine regimen. The use of mHealth should be strongly considered in mass vaccination campaigns in future initiatives.
Author Summary
The World Health Organization (WHO) recently endorsed the creation of a global oral cholera vaccine (OCV) stockpile as part of an integrated, strategic framework to address the re-emerging threat that cholera causes worldwide. In conjunction, the WHO also called for continued monitoring and evaluation around the use of OCV in different settings. In response to the cholera epidemic in Haiti that began in October 2010, Partners In Health, an implementing partner of Haiti’s Ministry of Health, vaccinated 50,000 Haitians in two rural communities in the Artibonite Valley in 2012. In this paper, the authors describe the use of mobile health (mHealth) technology for data collection and geospatial mapping to document this rural OCV campaign, focusing on the utility, benefits, and challenges of mHealth in a reactive campaign in the midst of the ongoing epidemic.
Introducing a Dengue Vaccine to Mexico: Development of a System for Evidence-Based Public Policy Recommendations
Miguel Betancourt-Cravioto, Pablo Kuri-Morales, Jesús Felipe González-Roldán, Roberto Tapia-Conyer, the Mexican Dengue Expert Group Policy Platform | published 31 Jul 2014 | PLOS Neglected Tropical Diseases 10.1371/journal.pntd.0003009
No abstract

A Scale of Risk

Risk Analysis
July 2014 Volume 34, Issue 7 Pages 1161–1358
http://onlinelibrary.wiley.com/doi/10.1111/risa.2014.34.issue-7/issuetoc

Original Research Article
A Scale of Risk
Paolo Gardoni1,* and
Colleen Murphy2
Article first published online: 20 DEC 2013
DOI: 10.1111/risa.12150
Abstract
This article proposes a conceptual framework for ranking the relative gravity of diverse risks. This framework identifies the moral considerations that should inform the evaluation and comparison of diverse risks. A common definition of risk includes two dimensions: the probability of occurrence and the associated consequences of a set of hazardous scenarios. This article first expands this definition to include a third dimension: the source of a risk. The source of a risk refers to the agents involved in the creation or maintenance of a risk and captures a central moral concern about risks. Then, a scale of risk is proposed to categorize risks along a multidimensional ranking, based on a comparative evaluation of the consequences, probability, and source of a given risk. A risk is ranked higher on the scale the larger the consequences, the greater the probability, and the more morally culpable the source. The information from the proposed comparative evaluation of risks can inform the selection of priorities for risk mitigation.

Placebo use in vaccine trials: Recommendations of a WHO expert panel

Vaccine
Volume 32, Issue 37, Pages 4703-4812 (20 August 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/37

Placebo use in vaccine trials: Recommendations of a WHO expert panel
Pages 4708-4712
Annette Rid, Abha Saxena, Abdhullah H. Baqui, Anant Bhan, Julie Bines, Marie-Charlotte Bouesseau, Arthur Caplan, James Colgrove, Ames Dhai, Rita Gomez-Diaz, Shane K. Green, Gagandeep Kang, Rosanna Lagos, Patricia Loh, Alex John London, Kim Mulholland, Pieter Neels, Punee Pitisuttithum, Samba Cor Sarr, Michael Selgelid, Mark Sheehan, et al.
Abstract
Highlights
:: Placebo controls may be acceptable even when an efficacious vaccine exists, in the following four possible situations:
:: When developing a locally affordable vaccine.
:: When evaluating the local safety and efficacy of an existing vaccine.
:: When testing a new vaccine when an existing vaccine is not considered appropriate locally.
:: When determining the local burden of disease.

HPV vaccination among lesbian and bisexual women: Findings from a national survey of young adults

Vaccine
Volume 32, Issue 37, Pages 4703-4812 (20 August 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/37

HPV vaccination among lesbian and bisexual women: Findings from a national survey of young adults
Original Research Article
Pages 4736-4742
Annie-Laurie McRee, Mira L. Katz, Electra D. Paskett, Paul L. Reiter
Abstract
Background
Human papillomavirus (HPV) infection and associated cervical disease are common among all women, regardless of sexual identity, yet limited research has examined HPV vaccination among lesbian and bisexual women.
Methods
A national sample of lesbian and bisexual women ages 18–26 (n = 543) completed our online survey during Fall 2013. We used multivariable logistic regression to identify correlates of HPV vaccine initiation (receipt of at least 1 dose) and completion (receipt of all 3 recommended doses among initiators).
Results
Overall, 45% of respondents had initiated HPV vaccine and 70% of initiators reported completing the series. HPV vaccine initiation was higher among respondents who were students, had received a healthcare provider’s recommendation, perceived greater positive social vaccination norms, or anticipated greater regret if they did not get vaccinated and later got HPV. Initiation was lower among those who perceived greater HPV vaccine harms or greater barriers to getting the vaccine (all p < .05). HPV vaccine completion was higher among initiators who had a college degree while it was lower among those who perceived a greater likelihood of acquiring HPV or who anticipated greater regret if they got the vaccine and fainted (all p < .05). Among HPV vaccine initiators who had not yet completed the series, about half (47%) intended to get the remaining doses.
Conclusions
Many lesbian and bisexual women are not getting vaccinated against HPV. Healthcare provider recommendations and women’s health beliefs may be important leverage points for increasing vaccination among this population.

Vaccination perceptions of school employees in a rural school district

Vaccine
Volume 32, Issue 37, Pages 4703-4812 (20 August 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/37

Vaccination perceptions of school employees in a rural school district
Original Research Article
Pages 4766-4771
Janelle Macintosh, Karlen E. Luthy, Renea L. Beckstrand, Lacey M. Eden, Jennifer Orton
Abstract
Highlights
:: It is important to evaluate why school employees are not adequately vaccinated for highly virulent diseases, such as influenza and measles, mumps, and rubella.
:: Only about half of school employees in one rural Utah school district were adequately vaccinated against influenza.
:: About a third of school employees reported receiving a measles, mumps, and rubella vaccine during adulthood.
:: Even though almost half of school employees supported a vaccine mandate, no such vaccine requirement existed in the school district.
:: Public health officials, health care providers, and school administrators should collaborate to improve vaccination rates among school employees.

Healthcare workers under a mandated H1N1 vaccination policy with employment termination penalty: A survey to assess employee perception

Vaccine
Volume 32, Issue 37, Pages 4703-4812 (20 August 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/37

Healthcare workers under a mandated H1N1 vaccination policy with employment termination penalty: A survey to assess employee perception
Original Research Article
Pages 4786-4790
Lori Winston, Stephanie Wagner, Shu Chan
Abstract
The ethical debate over mandatory healthcare worker (HCW) influenza vaccination is a heated one. Our study hospital instituted a mandatory employee influenza vaccination policy for the 2009–2010 influenza season during the highly publicized pandemic of the H1N1 “Swine Flu.” Under this mandate there was no informed declination option, and termination of employment was the consequence for noncompliance. Our objective was to examine HCW perceptions of the H1N1 influenza virus, the vaccine, and the strict mandated vaccination policy. A survey was designed, distributed, and anonymously collected. In total, 202 completed questionnaires were obtained via accidental sampling by the investigators achieving a 100% response rate. Data analysis showed that 31.7% of surveyed HCWs felt the mandate was an infringement on their rights and 3.5% of HCWs would electively seek employment elsewhere. Significantly more nurses and clerks/technicians were opposed to the mandate compared to other types of employees. 96% felt that the mandating hospital should be liable should a significant adverse effect occur from receiving the vaccine. While the mandate helped to increase HCW influenza vaccination rates dramatically, the strict consequence of employment termination created negative feelings of coercion. Adopting a policy that includes a declination option with mandatory masking during influenza season might be a more widely acceptable and still adequate approach.

Developments in Viral Vector-Based Vaccines

Vaccines — Open Access Journal
(Accessed 2 August 2014)
http://www.mdpi.com/journal/vaccines

Review
Developments in Viral Vector-Based Vaccines
by Takehiro Ura, Kenji Okuda and Masaru Shimada
doi:10.3390/vaccines2030624 – published online 29 July 2014
Abstract:
Viral vectors are promising tools for gene therapy and vaccines. Viral vector-based vaccines can enhance immunogenicity without an adjuvant and induce a robust cytotoxic T lymphocyte (CTL) response to eliminate virus-infected cells. During the last several decades, many types of viruses have been developed as vaccine vectors. Each has unique features and parental virus-related risks. In addition, genetically altered vectors have been developed to improve efficacy and safety, reduce administration dose, and enable large-scale manufacturing. To date, both successful and unsuccessful results have been reported in clinical trials. These trials provide important information on factors such as toxicity, administration dose tolerated, and optimized vaccination strategy. This review highlights major viral vectors that are the best candidates for clinical use.

Forbes [Accessed 2 August 2014]

Forbes
http://www.forbes.com/
Accessed 2 August 2014

Robert Kennedy’s Dangerous Anti-Vaccine Activism
Steven Salzberg, Contributor Jul 20, 2014
Robert F. Kennedy Jr. is coming out with a new book that claims thimerosal in vaccines causes autism. This claim has been thoroughly discredited, but RFK Jr. believes that it’s all a big conspiracy and that he’s right. His crazy anti-vaccine views coupled with his fame make for an especially dangerous combination.

Vaccines Are A Medical Miracle-And The Best Value In Healthcare
Henry I. Miller, Contributor Jul 30, 2014
Thanks to the availability of safe, effective, affordable vaccines, parents of small children today know little of the fear–much less the reality–of deadly childhood diseases. Vaccines are the best value in our healthcare system, but a New York Times medical writer thinks they’re too expensive.